FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXEL SECURE TOUCH II SAFETY SYRINGE
K Number: K052103
·
Decision Oct 19, 2005
Classifications
1
FEI Numbers
130
Registration Numbers
130
Same Product Code
161
Applicant Total
12
Review Days
77
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Basic Information
- Device Name
- EXEL SECURE TOUCH II SAFETY SYRINGE
- K Number
- K052103
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5860
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Exelint Intl. Co.
- Date Received
- August 3, 2005
- Decision Date
- October 19, 2005
- Product Code
- MEG
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MEG | Syringe, Antistick | FDA class 2 | General Hospital |
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FDA 510(k)
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Other Clearances by Exelint Intl. Co.
| K Number | Device Name | ||
|---|---|---|---|
| K092172 | EXEL I.V. EXTENSION SET | Jan 4, 2010 | Substantially Equivalent |
| K031500 | EXCEL PRIMARY SOLUTION SET | Jul 25, 2003 | Substantially Equivalent |
| K011754 | EXEL SECURETOUCH PTP SYRINGE | Jan 22, 2003 | Substantially Equivalent |
| K020533 | EXEL VACULET BLOOD COLLECTION SET | Dec 2, 2002 | Substantially Equivalent |
| K022406 | EXEL SECURETOUCH SAFETY VACULET BLOOD COLLECTION SET | Sep 30, 2002 | Substantially Equivalent |
| K011757 | EXEL COMFORTPOINT INSULIN PEN NEEDLE | Jan 23, 2002 | Substantially Equivalent |
| K012879 | EXEL HUBER INFUSION SET WITH NEEDLELESS INJECTION SITE | Jan 17, 2002 | Substantially Equivalent |
| K013037 | EXCEL A.V FISUTAL NEEDLE SET | Dec 7, 2001 | Substantially Equivalent |
| K011405 | EXEL INJECTION PLUG WITH CAP | Sep 27, 2001 | Substantially Equivalent |
| K010404 | EXEL I.V. ADMINISTRATION SET | Aug 30, 2001 | Substantially Equivalent |